Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.

Bone Deformity Clinical Trial

— ROSA  

Official title:

A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570606
• Other study ID #: ROSA01
• Status: Recruiting
• Start date: June 13, 2019
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: Ceramisys Ltd
• Contact: Rebecca Hutchinson
• Phone: +441142327070
• Email: b.hutchinson[@]ceramisys.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

Spine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.

Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;

Exclusion Criteria:

Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Related Conditions & MeSH terms

• Bone Deformity
• Congenital Abnormalities

Intervention

Device:
• bone graft substitute
orthopaedic or spine bony defects

Locations

Country	Name	City	State
United Kingdom	Sandwell and West Birmingham NHS Trust of City Hospital	Birmingham
United Kingdom	The Royal Orthopaedic Hospital NHS Foundation Trust	Birmingham
United Kingdom	Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster	South Yorkshire
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent
United Kingdom	Taunton and Somerset NHS Foundation Trust	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
Ceramisys Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints will be successful radiographic bone repair.	Bone formation and material resorption, observable by x-ray/MRI	12 months